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Clinical Trials/NCT01231997
NCT01231997CompletedPhase 1

Clinical Study to Investigate the Safety and Pharmacokinetics of Udenafil Tablet in Renal Impaired Male Patients

Asan Medical Center1 site in 1 country27 target enrollmentStarted: November 2009Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
27
Locations
1
Primary Endpoint
Pharmacokinetics (AUC and Cmax)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study is designed to assess the effect of renal impairment on the pharmacokinetics, safety and tolerability of udenafil in subjects with renal impairment compared to healthy subjects.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
19 Years to 64 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Adult males aged 19 to 64 years at screening.
  • •Subjects with body weight ≥ 55 kg and within ±30% of the ideal body weight : Ideal body weight = (height [cm] - 100)x0.
  • •Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.

Exclusion Criteria

  • •Subjects with the test results of QTc > 430 ms or non-sinus cardiac rhythm by ECG analysis.
  • •Subjects with hypotension or hypertension.
  • •Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study.
  • •Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.

Arms & Interventions

Healthy Volunteers

Experimental

Intervention: Udenafil (Drug)

Patients with mild renal impairment

Experimental

Intervention: Udenafil (Drug)

Patients with moderate renal impairment

Experimental

Intervention: Udenafil (Drug)

Patients with severe renal impairment

Experimental

Intervention: Udenafil (Drug)

Outcomes

Primary Outcomes

Pharmacokinetics (AUC and Cmax)

Time Frame: up to 48 hours

Secondary Outcomes

  • Safety(up to 48 hours)

Investigators

Sponsor Class
Other

Study Sites (1)

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